Application 211925
- Type
- ANDA
- Sponsor
- MICRO LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | TABLET;ORAL | EQ 12.5MG BASE;5MG | No | No |
| 002 | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | TABLET;ORAL | EQ 25MG BASE;10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42571-302 | Chlordiazepoxide and Amitriptyline Hydrochloride | Chlordiazepoxide and Amitriptyline Hydrochloride | Micro Labs Limited | ANDA | Current |
| 42571-303 | Chlordiazepoxide and Amitriptyline Hydrochloride | Chlordiazepoxide and Amitriptyline Hydrochloride | Micro Labs Limited | ANDA | Current |